BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18796469 · Received February 28, 2024

    Report

    Report Number
    3004455125-2024-00006
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    October 11, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    PMA / PMN Number
    K173381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FAULT: IMAGE DROP OUT DURING SURGERY X2 IMAGE ROUTED TO 2 DISPLAYS AND BOTH THE VIDEO WENT DOWN : LIFE LINE CONNECTED TO DISLAY WITH THE MNA-240 TOOK OVER. 1: PATIENT WAS NOT INJURED. 2: LIFELINE WAS ACTIVATED, AND AFTER A WHILE AUTOMATICALLY SWITCHED BACK DOWN NEXXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451304 BARCO NEXXISOR DXJ BARCO NV NEXXISOR / MNA-440 ENC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown